a study on Prostate Cancer
This is a tissue and blood collection protocol requiring image-guided biopsies of metastatic prostate cancer. Whenever possible, a new bone lesion or new/progressing soft tissue lesion will be chosen for biopsy as opposed to radiographically stable lesion. Patients will be enrolled in parallel into one of five patient cohorts based modality of planned or recently initiated systemic therapy, as well as disease setting: (A) Androgen signaling inhibitor, (B) Immunotherapy, (C) Chemotherapy, (D) Targeted therapy, or (E) Castration-sensitive disease. Patients in cohort E will be enrolled in one of two groups: Group 1 (treatment-naïve), and Group 2 (pre-treated) (see previous section for definition). Patients enrolled in Cohorts A-D, as well as Cohort E group 1, will undergo baseline tumor biopsy prior to initiation of next line of systemic therapy. For patients enrolled in Cohort E, group 2, patients will undergo the first tumor biopsy between 6-8 months after first dose of LHRH analogue delivered as treatment for metastatic prostate cancer.
Precision Oncology and Molecular Targeting in Advanced Prostate Cancer: Identifying Predictive Markers of Response (The "PROMOTE" Study)
After performing tumor biopsies and processing the biopsies, the researchers will perform comprehensive molecular analysis using established methods for RNA and DNA sequencing. The researchers will also collect blood samples (for circulating tumor DNA, plasma, and serum) and circulating tumor cells from participating patients. Residual paraffin-embedded blocks, frozen tissue, and blood products (serum, plasma, and circulating cells) will be stored in a repository for future testing of candidate predictive markers identified during microarray analysis. Whenever possible, the researchers will utilize a CLIA-certified laboratory to identify genetic mutations within mCRPC tumors to provide genetic information that can be returned to patient to potentially inform treatment decisions.
Following biopsy, patients will be treated per investigator discretion, with treatment corresponding to assigned patient cohort. Patients will be evaluated every 3 months for response to therapy, with serum PSA and staging scans as clinically indicated. Outcomes on treatment post-biopsy will be recorded, including maximal PSA decline, date of radiographic progression.
For cohorts A-D (mCRPC), at the time of disease progression by PCWG2 criteria, patients may undergo optional repeat tumor biopsy, along with blood collection for analysis of circulating tumor DNA and CTCs.
For cohort E, group 1, patients will undergo optional repeat tumor biopsy 6-8 months after the start of androgen deprivation therapy, along with mandatory blood collection for ctDNA and CTC analysis.
For cohort E, group 2, patients will undergo optional repeat tumor biopsy at the time of development of castration resistance as defined by PCWG2 criteria, along with mandatory blood collection for ctDNA and CTC analysis.
All patients will be followed for long term survival with every 3 month telephone calls and/or chart review.
Prostate Cancer Castration Resistant Metastatic
For males ages 18 years and up
PSA Progression: PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least one week apart.
Group 1 (ADT-Naïve): Patients who have not received LHRH analogue, LHRH antagonist or any anti-androgen for metastatic disease. Prior use of androgen deprivation therapy in the(neo)adjuvant, salvage, or biochemically recurrent setting is allowed provided the last day of effective androgen deprivation was more than 12 months prior to study entry.Androgen deprivation therapy must be planned to start within 28 days of baseline tumor biopsy.
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02735252.
© The Regents of the University of California